NCT07543029

Brief Summary

Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Methodology and Sample: Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026. Sample Size: Based on G\*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org. Intervention: Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported. Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support). Data Collection Tools: Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 14, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Primiparitynewbornbreastfeedingmaternal rolekangaroo care

Outcome Measures

Primary Outcomes (2)

  • LATCH Breastfeeding Assessment Tool

    Developed by Deborah Jehsen and Sheila Wallace in 1993 to assess breastfeeding, it consists of five parameters, each item scored between 0 and 2 points. The highest possible score on the scale is 10, and the lowest is 0. The validity and reliability of the LATCH Breastfeeding Assessment Tool in Turkey was determined by Yenal and Okumuş in 2003, and it was found to be valid and reliable for the Turkish population. The validity and reliability coefficient of the LATCH scale is alpha 0.82. The scale, consisting of 5 evaluation criteria, is formed by combining the first letters of the English words LATCH. The criteria are as follows; L: Latch on breast A: Audible swallowing T: Type of nipple C: Comfort breast/nipple. H: Baby holding position

    8 month

  • Semantic Difference Scale - Self-Assessment as a Mother

    Developed by Walker et al. (1986), this scale was designed to measure the evaluation dimensions of the concept of "self-assessment as a mother." The adaptation of the scale to Turkish society was done by Çalışır (2003). The scale consists of 11 pairs of opposing adjectives, distributed among 22 items. Each adjective pair is scored from 1 to 7. Three items (3, 7, 8) are evaluated using a reverse scoring system to prevent biased scoring by participants. A high total score on the scale indicates a positive self-assessment of motherhood (Walker et al., 1986). While Walker found the internal consistency coefficient to be between 0.81-0.85, Çalışır found the Cronbach Alpha internal consistency coefficient to be between 0.73-0.74 (Çalışır, 2003).

    8 month

Study Arms (2)

Kangaroo

EXPERIMENTAL

Mothers in this group will receive intermittent Kangaroo Mother Care (chest-to-chest contact) for 24 hours postpartum.

Behavioral: Kangaroo Mother Care

Control

NO INTERVENTION

Mothers in this group will receive standard hospital postpartum care protocols, including routine skin-to-skin contact and breastfeeding support.

Interventions

Newborns will be placed in an upright chest-to-chest position on the mother's bare chest. This intermittent skin-to-skin contact will be applied in sessions according to the mother's and newborn's stability and comfort, and will be maintained at regular intervals throughout the first 24 hours postpartum.

Kangaroo

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For mothers:
  • It must be the mother's first birth,
  • Birth must have been vaginal,
  • The mother must be healthy,
  • The mother must voluntarily participate in the study,
  • The mother must not have any communication-impairing conditions (language, cognitive problems, etc.),
  • For babies:
  • Birth weight must be between 2500-4000 grams;
  • The newborn must be healthy,
  • Exclusively breastfed,
  • The newborn must be at term gestation (38-42 weeks),
  • The newborn's Apgar score at 1 and 5 minutes must be above 7,
  • The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucak State Hospital

Rize, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gamzegül ALTAY, PhD

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamzegül ALTAY, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations